At a glance
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A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158
In Brief
A Phase 2 clinical trial evaluating Genomically Directed Monotherapy and Observation/Standard Therapy for Malignant Neoplasm of Breast and Breast Cancer. Completed, enrolled 193 participants across 29 sites.
Detailed Summary
This study will test the theory that therapy designed for each individual's tumor will improve outcomes over standard of care in a population that needs a better standard.
Study Details
Timeline
Interventions
Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:
Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.